XALACOM 50 MICROGRAMS/ML + 5MG/ML EYE DROPS SOLUTION

Transcript

Ref: 1646/110716/1/F

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Xalacom 50 micrograms/ml + 5mg/ml Eye Drops, Solution
(latanoprost / timolol maleate)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
Your medicine is called Xalacom 50 micrograms/ml
+ 5mg/ml Eye Drops, Solution but will be referred to
as Xalacom throughout this leaflet.

What is in this leaflet:
1 What Xalacom is and what it is used for
2 What you need to know before you use
Xalacom
3 How to use Xalacom
4 Possible side effects
5 How to store Xalacom
6 Contents of the pack and other
information
1

What Xalacom is and what it is used
for

Xalacom contains two medicines: latanoprost and
timolol. Latanoprost belongs to a group of medicines
known as prostaglandin analogues. Timolol belongs
to a group of medicines known as beta-blockers.
Latanoprost works by increasing the natural outflow
of fluid from the eye into the bloodstream. Timolol
works by slowing the formation of fluid in the eye.
Xalacom is used to reduce the pressure in your eye
if you have conditions known as open angle
glaucoma or ocular hypertension. Both these
conditions are linked to an increase in the pressure
within your eye, eventually affecting your eyesight.
Your doctor will usually prescribe you Xalacom
when other medicines have not worked adequately.
2

What you need to know before you
use Xalacom

Xalacom can be used in adult men and women
(including the elderly), but is not recommended for
use if you are less than 18 years of age.
Do not use Xalacom eye drops solution:
• if you are allergic (hypersensitive) to either of the
medicines in Xalacom (latanoprost or timolol),
beta-blockers, or any of the other ingredients of
Xalacom (listed in section 6)
• if you have now or have had in past respiratory
problems such as asthma, severe chronic
obstructive bronchitis (severe lung disease which
may cause wheeziness, difficulty in breathing
and/or long-standing cough)
• if you have serious heart problems or heart rhythm
disorders
• if you are pregnant (or trying to become pregnant)
• if you are breast-feeding
Warnings and precautions
Talk to your doctor or pharmacist before using
Xalacom if you have now or have had in the past:
• coronary heart disease (symptoms can include
chest pain or tightness, breathlessness or
choking), heart failure, low blood pressure
• disturbances of heart rate such as slow heart beat
• breathing problems, asthma or chronic obstructive
pulmonary disease
• poor blood circulation disease (such as Raynaud’s
disease or Raynaud’s syndrome)
• diabetes as timolol may mask signs and symptoms
of low blood sugar
• overactivity of the thyroid gland as timolol may
mask signs and symptoms
• you are about to have any kind of eye surgery
(including cataract surgery) or have had any kind of
eye surgery in the past
• you suffer from eye problems (such as eye pain,
eye irritation, eye inflammation or blurred vision)
• you know that you suffer from dry eyes
• you wear contact lenses. You can still use
Xalacom but follow the instructions for contact lens
wearers in section 3
• you know that you suffer from angina (particularly
a type known as Prinzmetal angina)
• you know that you suffer from severe allergic
reactions that would usually require hospital
treatment
• you have suffered or are currently suffering from a
viral infection of the eye caused by the herpes
simplex virus (HSV)
Tell your doctor before you have an operation that
you are using Xalacom as timolol may change
effects of some medicines used during anaesthesia.

In particular, speak to your doctor or pharmacist if
you know that you are taking any of the following
types of medicine:
• Prostaglandins, prostaglandin analogues or
prostaglandin derivates
• Beta-blockers
• Epinephrine
• Drugs used to treat high blood pressure such
as oral calcium channel blockers,
guanethidine, antiarrythmics, digitalis
glycosides or parasympathomimetics
• Quinidine (used to treat heart conditions and
some types of malaria)
• Antidepressants known as fluoxetine and
paroxetine
Xalacom with food and drink
Normal meals, food or drink have no effect on when
or how you should use Xalacom.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
Latanoprost and timolol have been found to have no
effect on male or female fertility in animal studies.
Driving and using machines
When you use Xalacom your vision may become
blurred for a short time. If this happens to you, do
not drive or use any tools or machines until your
vision becomes clear again.
Xalacom contains benzalkonium chloride
Xalacom contains a preservative called
benzalkonium chloride. This preservative may cause
eye irritation or disruption to the surface of the eye.
It can be absorbed by contact lenses and is known
to discolour soft contact lenses. Therefore, avoid
contact with soft contact lenses. See the instructions
for contact lens wearers in section 3.

3

How to use Xalacom

Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose for adults (including the
elderly) is one drop once a day in the affected
eye(s).
Do not use Xalacom more than once a day, because
the effectiveness of the treatment can be reduced if
you administer it more often.
Use Xalacom as instructed by your doctor until your
doctor tells you to stop.
Your doctor may want you to have extra checks on
your heart and circulation if you use Xalacom.
Contact lens wearers
If you wear contact lenses, you should remove them
before using Xalacom. After using Xalacom you
should wait 15 minutes before putting your contact
lenses back in.
Instructions for use
1. Wash your hands and sit or stand
comfortably.
2. Twist off the outer cap (which can
be thrown away).

Figure 2
4. Use your finger to gently
pull down the lower eyelid
of your affected eye.
5. Place the tip of the bottle
close to, but not touching
your eye.
6. Squeeze the bottle gently
so that only one drop goes
into your eye, then release
the lower eyelid.
7. After using Xalacom, press
a finger into the corner of
your eye, by the nose
(figure 4) for 2 minutes.
This helps to stop
latanoprost + timolol
getting into the rest of the
body.

Figure 3

Figure 4
Other medicines and Xalacom
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including using eye drops and medicines obtained
without a prescription.
Xalacom can affect or be affected by other
medicines you are using, including other eye
drops for the treatment of glaucoma. Tell your doctor
if you are using or intend to use medicines to lower
blood pressure, heart medicine or medicines to treat
diabetes.

8. Repeat in your other eye if your doctor has told
you to do this.
9. Put the protective inner cap back on the bottle.
If you use Xalacom with other eye drops
Wait at least 5 minutes between using Xalacom and
using the other eye drops.
If you use more Xalacom than you should
If you put too many drops in your eye you may
experience some minor irritation in your eye and
your eyes may water and turn red. This should pass
but if you are worried contact your doctor for advice.

If you swallow Xalacom
If you swallow Xalacom accidentally you should
contact your doctor for advice. If you swallow a lot of
Xalacom you may feel sick, have stomach pains,
feel tired, flushed and dizzy and start to sweat.
If you forget to use Xalacom
Carry on with the usual dosage at the usual time.
Do not take a double dose to make up to the dose
you have forgotten. If you are unsure about anything
talk to your doctor or pharmacist.
4

Possible side effects

Like all medicines this medicine can cause side
effects, although not everybody gets them.
You can usually carry on taking the drops, unless
the effects are serious. If you're worried, talk to a
doctor or pharmacist. Do not stop using Xalacom
without speaking to your doctor.
Listed below are the known side effects of using
Xalacom. The most important side-effect is the
possibility of a gradual, permanent change in your
eye colour. It is also possible that Xalacom might
cause serious changes in the way your heart works.
If you notice changes in your heart rate or heart
function you should speak to a doctor and tell them
you have been using Xalacom.
The following are known side effects of using
Xalacom:
Very common (may affect more than 1 in 10
people):
• A gradual change in your eye colour by
increasing the amount of brown pigment in the
coloured part of the eye known as the iris. If you
have mixed-colour eyes (blue-brown, grey-brown,
yellow-brown or green-brown) you are more likely
to see this change than if you have eyes of one
colour (blue, grey, green or brown eyes). Any
changes in your eye colour may take years to
develop. The colour change may be permanent
and may be more noticeable if you use Xalacom
in only one eye. There appears to be no problems
associated with the change in eye colour. The eye
colour change does not continue after Xalacom
treatment is stopped.
Common (may affect up to 1 in 10 people):

• Eye irritation (a feeling of burning, grittiness,

itching, stinging or the sensation of a foreign body
in the eye) and eye pain.

Uncommon (may affect up to 1 in 100 people):
• Headache
• Redness of the eye, eye infection (conjunctivitis),
blurred vision, watery eyes, inflammation of the
eyelids, irritation or disruption of the surface of the
eye
• Skin rashes or itching (pruritus)
Other side effects
Although not seen with Xalacom, the following
additional side effects have been seen with the
medicines in Xalacom (latanoprost and timolol) and
therefore might occur when you use Xalacom:
The following side effects have been seen with
latanoprost:
Infections and Infestations:
• Developing a viral infection of the eye caused by
the herpes simplex virus (HSV).
Immune System Disorders:
• Symptoms of allergic reaction (swelling and
redness of the skin and rash).
Psychiatric Disorders:
• Depression, memory loss, decreased sex drive,
inability to sleep, nightmares.
Nervous System Disorders:
• Dizziness, tingling or numbness in the skin,
changes in blood flow to the brain, worsening of
symptoms of myasthenia gravis (if you already
suffer from this condition), sudden fainting or
feeling you may faint (syncope).
Eye Disorders:
• Changes to the eyelashes and fine hairs around
the eye (increased number, length, thickness and
darkening), changes to the direction of eyelash
growth, swelling around the eye, swelling of the
coloured part of the eye (iritis/uveitus), swelling at
the back of the eye (macular oedema),
inflammation/irritation of the surface of the eye
(keratitis), dry eyes, fluid filled cyst within the
coloured part of the eye (iris cyst), light sensitivity
(photophobia), sunken eye appearance
(deepening of the eye sulcus).
Ear Disorders:

Like other medicines applied into eyes, Xalacom is
absorbed into the blood. The timolol portion of this
combination may cause similar side effects as seen
with intravenous and/or oral beta-blocking agents.
Incidence of side effects after topical ophthalmic
application is lower than when medicines are, for
example, taken by mouth or injected. Listed side
effects include reactions seen within the class of
beta-blockers when used for treating eye conditions:
• Generalized allergic reactions including swelling
beneath the skin that can occur in areas such as
the face and limbs and can obstruct the airway
which may cause difficulty swallowing or
breathing, hives or itchy rash, localized and
generalized rash, itchiness, severe sudden
life-threatening allergic reaction.
• Low blood glucose levels.
• Difficulty sleeping (insomnia), depression,
nightmares, memory loss.
• Fainting, stroke, reduced blood supply to the brain,
increases in signs and symptoms of myasthenia
gravis (muscle disorder), dizziness, unusual
sensations like pins and needles, and headache.
• Signs and symptoms of eye irritation (e.g. burning,
stinging, itching, tearing, redness), inflammation of
the eyelid, inflammation in the cornea, blurred
vision and detachment of the layer below the
retina that contains blood vessels following
filtration surgery which may cause visual
disturbances, decreased corneal sensitivity, dry
eyes, corneal erosion (damage to the front layer of
the eyeball), drooping of the upper eyelid (making
the eye stay half closed), double vision.
• Slow heart rate, chest pain, palpitations, oedema
(fluid build up), changes in the rhythm or speed of
the heartbeat, congestive heart failure (heart
disease with shortness of breath and swelling of
the feet and legs due to fluid build up), a type of
heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, Raynaud's phenomenon, cold
hands and feet.
• Constriction of the airways in the lungs
(predominantly in patients with pre-existing
disease), difficulty breathing, cough.
• Taste disturbances, nausea, indigestion,
diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with white silvery coloured
appearance (psoriasiform rash) or worsening of
psoriasis, skin rash.
• Muscle pain not caused by exercise.
• Sexual dysfunction, decreased libido.
• Muscle weakness/tiredness.
In very rare cases, some patients with severe
damage to the clear layer at the front of the eye (the
cornea) have developed cloudy patches on the
cornea due to calcium build-up during treatment.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effect not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
website: http://www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5

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How to store Xalacom

KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Store in a refrigerator.
After opening the bottle store it at room
temperature (do not store above 25°C)
Keep container in outer carton in order to protect
from light. Use within 4 weeks of opening.
Do not use this medicine after the expiry date
shown on the carton or bottle label.
If your eye drops become discoloured or show
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
Medicines should not be disposed of via
waste water or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.